Sr. Specialist Tech Engineering 35722

Inteldot•Juncos, PR

11h•Onsite

About The Position

The Facilities and Engineering Support Specialist will be a key contributor to maintaining the integrity and compliance of manufacturing facilities. This role involves providing crucial support in Quality Systems, including deviations, Corrective and Preventive Actions (CAPAs), Change Controls, documentation changes, pest control program management support, and OEFM electronic forms.

Requirements

Working knowledge of pharmaceutical/biotech processes.
Specialized industrial chilled water, cooling towers and HVAC systems expertise.
Familiarity with validation and documentation processes in a highly regulated environment.
Deviations and CAPA management capabilities
Problem solving skills with the ability to develop solutions to routine technical problems and apply engineering science for process improvements and troubleshooting.
Flexibility to work extended shift and/or weekends as per business needs.
Skills in the following areas: Negotiation, Persuasion, Collaboration, Project cost development, Conflict Resolution, Leadership, Team building & Schedule and Resources loading development.

Responsibilities

Provide primary support for Quality Systems activities, including deviations, CAPAs, Change Controls, and related quality documentation.
Investigate and document deviations from established procedures or specifications following applicable Standard Operating Procedures (SOPs).
Work closely with the Quality team and relevant stakeholders to initiate, implement, monitor, and close effective CAPAs in a timely manner.
Ensure Quality Systems records are complete, accurate, compliant, and inspection-ready.
Facilitate and manage documentation changes related to facilities and engineering processes.
Ensure that documentation changes adhere to regulatory guidelines, internal quality standards, and industry best practices.
Collaborate with relevant stakeholders to implement documentation changes efficiently.
Provide support for the creation, completion, review, routing, and tracking of OEFM electronic forms.
Ensure OEFM electronic forms are completed accurately, maintained in accordance with applicable procedures, and processed within required timelines.
Collaborate with F&E, Quality, and other cross-functional teams to resolve form-related questions or issues.
Support the transformation of the Pest Control program into a state of the art program.
Collaborate with external pest control vendors and internal teams to address and resolve any pest control issues.
Support the documentation and records related to the pest control program.
Support the Change Control process by evaluating proposed changes to facilities, utilities, equipment, and critical utilities.
Collaborate with stakeholders to assess the impact of changes and ensure proper documentation and implementation.
Maintain Change Control records and provide support during regulatory inspections.